Itoen Ltd
⚠️ Moderate Risk
FEI: 3003376988 • Shinjuku, Tokyo • JAPAN
FEI Number
3003376988
Location
Shinjuku, Tokyo
Country
JAPANAddress
4 Chome 28-10, Nishishinjuku, Shinjuku, Tokyo, Japan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/27/2003 | 20SGE01APPLE, CORE FRUIT JUICES OR CONCENTRATES | New York District Office (NYK-DO) | |
| 5/27/2003 | 25GCE99MIXED VEGETABLES, JUICE OR DRINK, N.E.C. | New York District Office (NYK-DO) | |
| 5/27/2003 | 25GCE99MIXED VEGETABLES, JUICE OR DRINK, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Itoen Ltd's FDA import refusal history?
Itoen Ltd (FEI: 3003376988) has 3 FDA import refusal record(s) in our database, spanning from 5/27/2003 to 5/27/2003.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Itoen Ltd's FEI number is 3003376988.
What types of violations has Itoen Ltd received?
Itoen Ltd has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Itoen Ltd come from?
All FDA import refusal data for Itoen Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.